Three Bills, But No Healthcare Triple Crown

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From the Warriors and the Capitals to Bob Baffert, Mike Smith, and Justify doing the near-impossible at the Belmont, June started off with some seriously big wins. We’ve also seen a lot of action on the healthcare front this week:

New line of attack on the ACA. The Department of Justice told a Texas court that the ACA’s individual mandate is no longer constitutional and that the DOJ would not defend it. It’s an extraordinary move, and if the argument is accepted, would undo many of the insurance rules – such as requiring coverage of pre-existing conditions – that are part of the Affordable Care Act.

The Bill & Melinda Gates Foundation is launching a nonprofit biotech to study treatments for malaria and other diseases potentially underserved due to poor ROI. The Boston-based institute will start with a $100M annual budget.

The National Organization for Rare Disordersblasted the increasing use of co-pay accumulators, especially for patients with a rare disease. Insurers have been using accumulators to diminish the impact a manufacturer rebates for medicine—pushing more costs onto patients.

Our colleague Peter Pitts also offered a commentary in the Washington Times, advocating the end of ‘game playing’ for a better healthcare ecosystem. Read on for more from The Week That Was…

►GRAB YOUR SPF: ADVOCATE FUNDING GETS MORE SUNSHINESenator Claire McCaskill (D-MO) is renewing her push to require drug companies to report funding they provide to patient advocates or professional societies. McCaskill is one of several prominent policymakers who have been critical of the relationship between industry and advocates, claiming the relationships help mute criticism of drug pricing and raise costs for the system..►OUR TAKEIt’s difficult to win public arguments against transparency but once information is public, it’s rarely as impactful as critics would believe. In general, life science companies should be open about their support for third parties. Avoiding questions funding for advocacy groups is more likely to create an issue than prevent one.

►RTT? MORE LIKE STATUS QUO FOR EAPPassage of a federal Right-to-Try bill isn’t expected to change the way pharmaceutical companies approach Expanded Access, at least not in the near term. Regular TWTW readers know the new law removes most of the FDA’s oversight if a company agrees to provide access to an experimental medicine to a terminally ill patient. But the primary reasons companies do not offer expanded access—such as available supply of medicine—are unrelated to the FDA and not impacted by the new law.►OUR TAKEIn the past, we've written about what the new federal RTT bill, now law, does. But what it doesn’t do is give patients the right to an experimental medicine; it just makes the regulatory pathway a little easier. However, the bill’s title and the broad way many describe the law are creating confusion among patients. If your expanded access communications don’t consider RTT, you should think about revising them. While your policies may not be changing, the way you describe them should in light of the new law. And if you need help updating your messages, drop us a line.

►MEDICAID EXPANSION HEADS EASTMedicaid expansion took steps forward in Virginia and Maine this week through two very different routes. After nearly a decade of political turmoil, Governor Northam signed legislation to expand Medicaid in the Old Dominion. Meanwhile in Maine, a federal judge ordered the state to move more quickly to operationalize an expansion that was approved by voters last year.As part of the ACA, states can choose to make Medicaid available to residents earning up to 138 percent of the federal poverty level ($16,750 for an individual) and have the federal government pay 90 percent of the bill.►OUR TAKEMedicaid expansion has been persistently popular, and is thought to increase utilization of primary care and mental health services, among others. But it’s subject to the political influences of a state, which may lead to unpredictable coverage for some patients in coming few years. Drug makers that serve a significant percentage of Medicaid beneficiaries should be considering your drug’s impact to state budgets and what you could do for patients if their coverage is jeopardized by changing coverage policy.

Before we close, let’s not forget Dad! Americans expect to spend more than $15 billion on Father’s Day gifts and outings this coming week. That’s a lot of coffee mugs and ties, but still 40 percent less than we spent celebrating Mom last month.